AIM: Adverse event reporting is on the rise
Although the FDA's Adverse Event Reporting System (AERS) database has been in existence since 1969, more than half of the incidents in it were received in the past decade, according to an article published online March 28 in the Archives of Internal Medicine.
These 2.2 million events represent a 1.65-fold increase from the prior decade, wrote Sheila Weiss-Smith, PhD, from the University of Maryland School of Pharmacy in Baltimore, and colleagues. "Report volume increased from 2000 to 2010 at a mean annual rate of 11.3 percent,” the authors continued.
AERS is a repository of passively reported adverse drug events designed as a safety net so the FDA can monitor all marketed drugs and detect serious safety problems. Weiss-Smith and colleagues sought to characterize the current reporting patterns.
Adverse event reports received by the FDA from January 1, 2000, through December 31, 2009, were identified in the public release of AERS. The researchers then identified the cohort from publicly released AERS data and data analysis.
Rates of reporting were calculated by dividing the total reports received annually by the FDA by the estimated number of visits to physician offices during which drugs were prescribed, ordered or provided (drug visits) in the U.S. from the National Ambulatory Medical Care Survey, the authors noted.
“Report rates, as a proportion of drug visits at physician offices, increased from 4.90 reports per 10,000 visits in 2000 to 6.83 reports per 10,000 visits in 2005,” the researchers found.
Adverse event reports for women were higher (55.3 percent), than for men, which is consistent with the distribution of drug visits by gender (58.5 percent female in 2005), the authors found. “In AERS, one-third (32.8 percent) of reports were among adults aged 30 to 64 years. Just 4.4 percent of reports were among patients younger than 18 years and 20.1 percent among patients 65 years and older.”
Among the 1,635,014 reports in which an outcome was reported, patients were hospitalized in 687,442, and in 247,171 reports, the patient died. “There remain significant limitations in the completeness and quality of reports,” Weiss-Smith and colleagues reported. “Reports missing data on age (37.4 percent) and sex (7.5 percent) have implications in the interpretation of studies limited to a particular subset and these key variables in the identification of duplicate reports.”
Recombinant DNA products predominated among the most frequently reported suspect drugs. The tumor necrosis factor (TNF) blockers were the first, third and fourth most frequently reported suspect drugs.
According to the authors, reporting was stimulated by the release of new safety information, with the 10 most commonly reported suspect drugs accounting for almost half a million reports, and may be of limited value for signal discovery.
“Reporting of adverse events to the FDA has increased dramatically, such that the majority of reports in the 40-year-old database were received just in the past decade,” the authors concluded. “What proportion of the increase in reports can be attributed to a real increase in adverse events…and how much represents increased reporting of suspected adverse events is unknown.”
These 2.2 million events represent a 1.65-fold increase from the prior decade, wrote Sheila Weiss-Smith, PhD, from the University of Maryland School of Pharmacy in Baltimore, and colleagues. "Report volume increased from 2000 to 2010 at a mean annual rate of 11.3 percent,” the authors continued.
AERS is a repository of passively reported adverse drug events designed as a safety net so the FDA can monitor all marketed drugs and detect serious safety problems. Weiss-Smith and colleagues sought to characterize the current reporting patterns.
Adverse event reports received by the FDA from January 1, 2000, through December 31, 2009, were identified in the public release of AERS. The researchers then identified the cohort from publicly released AERS data and data analysis.
Rates of reporting were calculated by dividing the total reports received annually by the FDA by the estimated number of visits to physician offices during which drugs were prescribed, ordered or provided (drug visits) in the U.S. from the National Ambulatory Medical Care Survey, the authors noted.
“Report rates, as a proportion of drug visits at physician offices, increased from 4.90 reports per 10,000 visits in 2000 to 6.83 reports per 10,000 visits in 2005,” the researchers found.
Adverse event reports for women were higher (55.3 percent), than for men, which is consistent with the distribution of drug visits by gender (58.5 percent female in 2005), the authors found. “In AERS, one-third (32.8 percent) of reports were among adults aged 30 to 64 years. Just 4.4 percent of reports were among patients younger than 18 years and 20.1 percent among patients 65 years and older.”
Among the 1,635,014 reports in which an outcome was reported, patients were hospitalized in 687,442, and in 247,171 reports, the patient died. “There remain significant limitations in the completeness and quality of reports,” Weiss-Smith and colleagues reported. “Reports missing data on age (37.4 percent) and sex (7.5 percent) have implications in the interpretation of studies limited to a particular subset and these key variables in the identification of duplicate reports.”
Recombinant DNA products predominated among the most frequently reported suspect drugs. The tumor necrosis factor (TNF) blockers were the first, third and fourth most frequently reported suspect drugs.
According to the authors, reporting was stimulated by the release of new safety information, with the 10 most commonly reported suspect drugs accounting for almost half a million reports, and may be of limited value for signal discovery.
“Reporting of adverse events to the FDA has increased dramatically, such that the majority of reports in the 40-year-old database were received just in the past decade,” the authors concluded. “What proportion of the increase in reports can be attributed to a real increase in adverse events…and how much represents increased reporting of suspected adverse events is unknown.”